An FDA rule that sought to prohibit the use of electrical stimulation devices to combat self-harming or aggressive behavior has been overturned by a federal appeals court. (FDA/Flickr)
The Food and Drug Administration has again been pushed back by a federal appeals court in its years-long push to ban devices used to deliver electric shocks to people with developmental disabilities.
The United States Court of Appeals for the DC Circuit issued an order late last month rejecting the FDA’s offer to rehear a case centered on a settlement finalized in 2020 banning so-called devices electrical stimulation. The devices send electric shocks through electrodes attached to the skin to condition people not to engage in self-harming or aggressive behaviors.
Earlier this year, the DC Circuit Court of Appeals struck down the FDA rule after three of the judges on the panel heard the case. The agency retaliated, asking for the case to be brought before the court’s 11 judges, but now that effort has been denied.
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These are devices intended for use at a single facility in the United States – the Judge Rotenberg Educational Center in Canton, Mass., which serves children and adults with developmental disabilities as well as those with behavioral and emotional.
For years, disability advocates have worked to end the use of skin shock devices, arguing that they are torturous. Proponents of the Rotenberg Center, however, say electrical stimulation devices are a last resort for people with severe behaviors that have not responded to other treatments.
In finalizing the ban last year, the FDA said the devices posed an “unreasonable and substantial risk of illness or injury,” citing evidence of psychological and physical risks, including burns, tissue damage, aggravation underlying symptoms, depression, anxiety and post-traumatic effects. stress disorder.
Advocates from the Autistic Self Advocacy Network, which has long fought to end the use of skin shock devices, said in a statement they were “outraged” by the court’s decision not to reconsider the case, allowing the Rotenberg Center to continue to use the devices. .
The Rotenberg Center sued to end the ban, leading DC Circuit Court of Appeals judges to conclude in July that the FDA had exceeded its authority. The court opinion said the agency could ban a device, but the FDA erred because it only banned electrical stimulation devices for the purpose of treating aggressive behavior or self-harm while still allowing the devices. for other uses.
“ASAN calls on the FDA to do whatever it takes to reinstate a ban by immediately reintroducing a new rule that would address the court’s concerns while effectively banning these devices,” the statement said. “The devices used at the Judge Rotenberg Center are very different from devices used for other purposes, so this should be easy for the FDA to do.”
The FDA declined to comment on the matter.
For his part, however, Judge Rotenberg Center said in a statement that he was “pleased” the court decided not to reconsider the case.
“The court’s decision allows clients to receive court-approved and monitored graduated electronic deceleration (GED) treatment as part of its holistic treatment plan for aggressive behavior or profound self-harm,” the statement read. “GED is used when all other treatments have failed and its recipients risk serious bodily harm or even death without it. Treatment allows these people to learn, to live in the community, to enjoy visits with their families and, above all, to be safe and free from chemical or physical constraints.